Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2001-02-14
2002-09-24
Carlson, Karen Cochrane (Department: 1653)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S322000, C514S277000, C514S437000, C514S450000, C514S276000, C424S442000
Reexamination Certificate
active
06455546
ABSTRACT:
FIELD OF THE INVENTION
The present invention generally relates to a method for promoting ovulation, parturition and lactation in female mammals. More particularly, the present invention is directed to a method of administering a dopamine D
2
receptor antagonist, such as domperidone, to a female mammal for altering hormonal levels in the animal in order to promote ovulation, parturition or lactation.
BACKGROUND OF THE INVENTION
Breeders of various animals, such as horses and other livestock, face many problems in getting the animals to breed properly. For instance, some female mammals fail to ovulate and fall into heat in regular intervals. Mammals that exhibit a prolonged period of inactivity between two periods of heat are described as being anestrous. Anestrous female mammals will not accept the male and are incapable of conceiving offspring.
Another problem breeders experience is the inability of some mammals to prepare for and give birth after the mammals have become pregnant and the fetus is ready to be born. In preparation for and during the act of giving birth, a process known as parturition, the pregnant mammal should experience cervical relaxation, swelling of the vulva, and relaxation of ligaments around the pelvis. Without these events occurring, the mammal is not capable of giving natural, unassisted birth. Further, should these events not occur, the health of the mother and of the unborn offspring are at grave risk.
Another problem commonly experienced by breeders is the inability of mammals to produce and secrete milk after giving birth. The condition of failing to lactate properly after child birth is referred to as agalactia, and is especially prevalent in mares and other livestock. Should the mammal not lactate properly, the offspring must then be bottle fed which is time consuming, labor intensive, and significantly adds to the cost of raising the livestock.
Each of the problems mentioned above can be caused to a great extent by hormonal imbalance or by hormonal irregularities. Hormones released in the body are primarily responsible for initiating ovulation, parturition, and lactation in mammals. Thus, if hormones are not released in the body at particular critical times, the above described problems can be experienced.
For instance, hormones can be prevented from being released in the body by various chemical agents. One such known chemical agent is dopamine. Dopamine is a decarboxylated form of dopa. Dopamine is believed to be produced by the body when it is necessary to suppress hormone secretion. Dopamine suppresses hormone release by binding to and tying up receptors on the anterior pituitary, an endocrine gland located at the base of the brain not far from the hypothalamus. By binding to the anterior pituitary, the gland is prevented from receiving a stimulus hormone that causes it to release other hormones such as those necessary for ovulation, parturition, and lactation.
Although dopamine is necessary during particular periods for keeping hormone levels in the body within controlled ranges, excess levels of dopamine can adversely interfere with the process of reproduction. Also, besides dopamine, there are other chemical agents that can interfere with or prevent hormone secretion, adversely affecting biological processes.
Thus, a need exists for a method of promoting follicular growth and ovulation, parturition, and lactation in female mammals. A need also exists for treating anestrous mammals, agalactic mammals, and mammals that fail to prepare for parturition when a fetus is ready to be born. A further need exists for a chemical agent that antagonizes dopamine and other chemicals that act in a similar manner in order to counteract hormonal imbalance and irregularities.
SUMMARY OF THE INVENTION
The present invention recognizes and addresses the foregoing disadvantages, and others of prior art constructions and methods.
Accordingly, it is an object of the present invention to provide a process for promoting ovulation and for treating anestrous mammals.
Another object of the present invention is to provide a method for promoting parturition in a pregnant mammal that is at the end of the pregnancy cycle.
It is another object of the present invention to provide a process for promoting lactation and for treating agalactia in mammals that have just given birth.
Still another object of the present invention is to provide a process for controlling hormonal release in the body.
Another object of the present invention is to provide a method for altering hormone levels in the body of a mammal by administering to the mammal a dopamine antagonist.
It is another object of the present invention to provide a process for treating a mammal that has excess levels of dopamine and other similar acting agents within its body.
These and other objects of the present invention are achieved by providing a method for promoting follicular growth and ovulation, for preparing a mammal for parturition, and for promoting lactation by administering to a female mammal a composition. The composition contains a dopamine D
2
receptor antagonist. For instance, in one embodiment, the composition can contain domperidone.
The present inventor has used domperidone in the past for treating animals suffering from fescue toxicosis. For instance, the present inventor's prior work is disclosed in U.S. Pat. No. 5,372,818 entitled “Method of Treating Fescue Toxicosis with Domperidone”, which is incorporated herein by reference in its entirety. In U.S. Pat. No. 5,372,818, it was discovered not only that domperidone is an effective agent for treating fescue toxicosis, but that domperidone does not substantially cross the blood brain barrier. Therefore, domperidone can be administered to animals while avoiding substantial adverse behavioral and neurological side effects. Such neuroleptic side effects have been observed in animals exposed to other D
2
receptor antagonists such as the drugs, metoclopramide and sulpiride.
Although U.S. Pat. No. 5,372,818 provides great advances in the art for treating animals infected with fescue toxicosis, various advantages, aspects and features of the present invention remain absent from the present inventor's prior patent.
According to the present invention, ovulation, parturition or lactation can be promoted by administering to a mammal a composition containing a dopamine D
2
receptor antagonist, such as domperidone. The D
2
receptor antagonist can be administered to the mammal in an amount from about 0.08 mg to about 3.3 mg per kilogram of body weight of the mammal. The D
2
receptor antagonist can be administered to the mammal either orally or subcutaneously.
Specifically, when using domperidone to promote follicular growth and ovulation, domperidone can be orally administered at a concentration of from about 0.2 mg to about 3.3 mg per kilogram weight of said mammal. In one preferred embodiment, the dosage of domperidone is about 0.55 mg per kilogram weight of the mammal.
When administered subcutaneously, the dosage can be from about 0.08 mg to about 1.32 mg and particularly around 0.22 mg per kilogram weight of the mammal.
When attempting to promote parturition, udder development, and lactation, on the other hand, domperidone can be administered orally to a mammal at a dosage of from about 0.2 mg to about 3.3 mg and particularly at about 1.1 mg per kilogram weight of the mammal. When administered subcutaneously, the dosage of domperidone can be from about 0.08 mg to about 1.32 mg and particularly at about 0.44 mg per kilogram weight of the mammal.
All of the above dosage levels according to the present invention can be given daily. Although unknown, it is believed that the treatments cause hormonal levels in the mammal to change for promoting either ovulation, parturition or lactation. Unexpectedly, it has also been discovered that a dopamine D
2
receptor antagonist such as domperidone may also cause an increase in feed intake in the mammal resulting in weight increases.
Other objects, features and aspects of the present invention are discussed i
Carlson Karen Cochrane
Clemson University
Dority & Manning
Kam Chih-Min
LandOfFree
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